Identifying treatable features of severe asthma to create personalized treatment plans
The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
This project will test whether finding each adult patient's modifiable 'treatable traits' and using a tailored bundle of treatments can improve control and quality of life for people with severe asthma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Chao Yang Hospital Academic / other |
| Locations | 10 sites (Beijing, Beijing Municipality and 9 other locations) |
| Trial ID | NCT07136025 on ClinicalTrials.gov |
What this trial studies
This multicenter effort enrolls adults with severe, uncontrolled asthma at tertiary hospitals and performs a comprehensive, multidisciplinary evaluation including lung function tests, fractional exhaled nitric oxide (FeNO), blood routine, allergen IgE, chest CT, and detailed questionnaires. Investigators will map the distribution of potentially modifiable traits and assign individualized cluster management compared with routine asthma treatment. Outcomes such as asthma control and quality of life will be followed over six months to see how trait-guided bundles affect symptoms and exacerbations. The project aims to link specific treatable characteristics to patient-centered outcomes to inform personalized care pathways.
Who should consider this trial
Good fit: Adults aged 18–79 with a diagnosis of severe, uncontrolled asthma per 2024 GINA criteria despite high‑dose ICS plus LABA who can undergo multidisciplinary evaluation and a six-month follow-up are ideal candidates.
Not a fit: Patients with other major destructive lung diseases (for example severe bronchiectasis or active pulmonary tuberculosis), recent major surgery, recent myocardial infarction, or other exclusions listed may not benefit from this personalized asthma approach.
Why it matters
Potential benefit: If successful, the approach could lead to personalized treatment plans that improve asthma control, reduce exacerbations, and enhance quality of life for people with severe asthma.
How similar studies have performed: Similar 'treatable traits' approaches have shown promise in smaller or single-center studies but remain an emerging strategy that requires larger, multicenter validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years, and \<80 years with a definite diagnosis of asthma for at least 6 months * Patients met the 2024 GINA criteria for severe asthma, which was defined as "uncontrolled" asthma (frequent asthma symptoms, or frequent acute exacerbations) despite high-dose inhaled corticosteroids (ICS) plus long-acting β2-receptor antagonists (LABAs), or worsening of symptoms after slight tapering of high-dose therapy. * They were willing to accept multi-disciplinary and multi-dimensional evaluation and signed informed consent * Informed consent was obtained and patients were able to participate in the study and 6-month follow-up according to the protocol Exclusion Criteria: * The presence of numerous other lung tissue destructive diseases, such as severe bronchiectasis or pulmonary tuberculosis. * Chest surgery or abdominal surgery in the past 3 months * Eye surgery had been performed within the past 3 months * Myocardial infarction within the previous 3 months * Anti-tuberculosis treatment is ongoing * Women who are pregnant and lactating * Macrolide use within 4 weeks before the screening period * Treatment with anti-ige, anti-IL-5, or anti-IL-5R within 4 weeks before the screening period * Inhaled ICS+LABA+ long-acting anticholinergic agent (LAMA) for 4 weeks prior to the screening period 4. Allergy to macrolides * QTc interval prolongation \>480ms * Taking medications that interact with azithromycin, causing QTc prolongation or existing ECG abnormalities, may lead to arrhythmia
Where this trial is running
Beijing, Beijing Municipality and 9 other locations
- Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
- Beijing Tiantan Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
- The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
- The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
- The First Affiliated Hospital of Guangzhou Medical University — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Kewu Huang, professor
- Email: kewuhuang@126.com
- Phone: 8613601234681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.